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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003616-52 | EudraCT Number | EudraCT |
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To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy subjects aged 45-64 | Experimental | Sequential Crossover to Placebo or BI 655075 |
|
| healthy elderly subjects aged 65-80 year | Experimental | Sequential Crossover to Placebo or BI 655075 |
|
| mild renal impairment aged 45-80 years | Experimental | Sequential Crossover to Placebo or BI 655075 |
|
| mod renal impairment aged 45-80 years | Experimental | Sequential Crossover to Placebo or BI 655075 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 655075 | Drug |
| ||
| BI 655075 |
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time | Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later. | End of last infusion and 10 minutes after completion of last infusion of BI 655075 |
| The Percentage of Subjects With Drug-related Adverse Events | The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period. | From baseline up to the start of follow-up period (from Day 1 to Day 35) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC0-infinity. PK/PD sampling time: (p=predose, D=day)
|
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1321.2.1 Boehringer Ingelheim Investigational Site | Antwerp | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28230262 | Derived | Norris S, Ramael S, Ikushima I, Haazen W, Harada A, Moschetti V, Imazu S, Reilly PA, Lang B, Stangier J, Glund S. Evaluation of the immunogenicity of the dabigatran reversal agent idarucizumab during Phase I studies. Br J Clin Pharmacol. 2017 Aug;83(8):1815-1825. doi: 10.1111/bcp.13269. Epub 2017 Apr 6. | |
| 27317414 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 Ida / Placebo | Subjects received dabigatran (DE) 220 mg plus idarucizumab (Ida) 5g followed by dabigatran 220 mg plus placebo 5g (high dose) |
| FG001 | Placebo / 5 Ida | Subjects received dabigatran (DE) 220 mg plus placebo 5g followed by dabigatran 220 mg plus Ida 5g (high dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Placebo | Drug |
|
| BI 655075 | Drug |
|
| Placebo | Drug |
|
| Placebo | Drug |
|
| Placebo | Drug |
|
| BI 655075 | Drug |
|
| From Day 4 to Day 9 (details in description) |
| AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h) | PK/PD sampling time:(d=dose,D=Day,p=predose)
| from 2h to12h of post DE dose at steady state (details in description) |
| Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2) | Urinary excretion of sum dabigatran from the time point t1 to t2 at steady state. PK Urine sampling time: Urine sampling relative to first DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h. Ae0-26,ss was not measured in Period 3 (re-exposure period). Ae0-74,ss was not measured in healthy subjects aged 45 to 64 years. | From 0 to 74h post of last DE dose (details in description) |
| Cmax (Maximum Measured Concentration of the Ida in Plasma) | Cmax. PK/PD sampling time: (p=predose, D=day)
| From Ida administration to 4 days post dose (details in description) |
| Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h) | Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time point 6 h). PK Urine sampling time: Urine sampling relative to DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h. | from 0 to 6 hours of post Ida dose (details in description) |
| Glund S, Stangier J, van Ryn J, Schmohl M, Moschetti V, Haazen W, De Smet M, Gansser D, Norris S, Lang B, Reilly P, Kreuzer J. Effect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study. Clin Pharmacokinet. 2017 Jan;56(1):41-54. doi: 10.1007/s40262-016-0417-0. |
| 27150693 | Derived | Glund S, Stangier J, van Ryn J, Schmohl M, Moschetti V, Haazen W, De Smet M, Gansser D, Norris S, Lang B, Reilly P, Kreuzer J. Restarting Dabigatran Etexilate 24 h After Reversal With Idarucizumab and Redosing Idarucizumab in Healthy Volunteers. J Am Coll Cardiol. 2016 Apr 5;67(13):1654-1656. doi: 10.1016/j.jacc.2016.01.043. No abstract available. |
| FG002 | 2.5 Ida / Placebo | Subjects received dabigatran (DE) 220 mg plus Ida 2.5g followed by dabigatran 220 mg plus placebo 2.5g (medium dose) |
| FG003 | Placebo / 2.5 Ida | Subjects received dabigatran (DE) 220 mg plus placebo 2.5g followed by dabigatran 220 mg plus Ida 2.5g (medium dose) |
| FG004 | 1 Ida / Placebo | Subjects received dabigatran (DE) 220 mg plus Ida 1g followed by dabigatran 220 mg plus placebo 1g (low dose) |
| FG005 | Placebo / 1 Ida | Subjects received dabigatran (DE) 220 mg plus placebo 1g followed by dabigatran 220 mg plus Ida 1g (low dose) |
| Healthy Subjects Aged 45-64 |
|
| Healthy Subjects Aged 65-80 |
|
| Subjects With Mild Renal Impairment |
|
| Subjects With Moderate Renal Impairment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Treated Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Subjects Group | The total subjects group contains the following sub-groups: high dose (5 g idarucizumab), healthy, aged 45-64 yrs: high dose (5 g idarucizumab), healthy elderly, aged 65-80 yrs: high dose (5 g idarucizumab), mild renal impairment (RI), aged 45-80 yrs: high dose (2.5 g + 2.5 g idarucizumab), with moderate RI, aged 45-80 yrs: medium dose (2.5 g idarucizumab), healthy, aged 45-64 yrs: low dose (1 g idarucizumab), healthy elderly, aged 65-80 yrs: low dose (1 g idarucizumab), with mild RI, aged 45-80 yrs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time | Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later. | PD Set (PDS): The PDS included all subjects from the TS who had at least 1 evaluable predose and on-treatment coagulation test measurement value for at least 1 coagulation test and who did not have important protocol violation relevant to the evaluation of PD. | Posted | Number | percentage of participants | End of last infusion and 10 minutes after completion of last infusion of BI 655075 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | The Percentage of Subjects With Drug-related Adverse Events | The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period. | Treated Set (TS): All randomised subjects who received at least 1 dose of trial medication were included in the treated set. | Posted | Number | percentage of participants | From baseline up to the start of follow-up period (from Day 1 to Day 35) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC0-infinity. PK/PD sampling time: (p=predose, D=day)
| Pharmacokinetic Set -Ida (PKS-Ida): included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | From Day 4 to Day 9 (details in description) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h) | PK/PD sampling time:(d=dose,D=Day,p=predose)
| PKS-DE: The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | from 2h to12h of post DE dose at steady state (details in description) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2) | Urinary excretion of sum dabigatran from the time point t1 to t2 at steady state. PK Urine sampling time: Urine sampling relative to first DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h. Ae0-26,ss was not measured in Period 3 (re-exposure period). Ae0-74,ss was not measured in healthy subjects aged 45 to 64 years. | Pharmacokinetic Set - DE (PKS-DE): The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg | From 0 to 74h post of last DE dose (details in description) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Cmax (Maximum Measured Concentration of the Ida in Plasma) | Cmax. PK/PD sampling time: (p=predose, D=day)
| PKS-Ida | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | From Ida administration to 4 days post dose (details in description) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h) | Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time point 6 h). PK Urine sampling time: Urine sampling relative to DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h. | PKS-Ida: The PKS-Ida included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | umol | from 0 to 6 hours of post Ida dose (details in description) |
|
From the study drug administration up to start of follow-up period (from Day 1 to Day 35).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran Etexilate (DE) | subjects with Dabigatran etexilate (DE) treatment | 0 | 46 | 13 | 46 | ||
| EG001 | Low (1g) Idarucizumab Dose | Subjects with low 1g idarucizumab dose treatment | 0 | 14 | 4 | 14 | ||
| EG002 | Medium (2.5g) Idarucizumab Dose | Subjects with medium (2.5g) idarucizumab dose treatment | 0 | 12 | 1 | 12 | ||
| EG003 | High (5g) Idarucizumab Dose | Subjects with high (5g) idarucizumab dose treatment | 0 | 26 | 2 | 26 | ||
| EG004 | Low (1g) Placebo Dose | Subjects with low (1g) placebo dose treatment | 0 | 14 | 3 | 14 | ||
| EG005 | Medium (2.5g) Placebo Dose | Subjects with medium (2.5g) placebo dose treatment | 0 | 12 | 3 | 12 | ||
| EG006 | High (5g) Placebo Dose | Subjects with high (5g) placebo dose treatment | 0 | 26 | 0 | 26 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Application site dermatitis | General disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594745 | idarucizumab |
Not provided
Not provided
Not provided
| at least one time point, ECT |
|
| both time points, ECT |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| OG002 | 220 mg/5 g HS 45-64 Yrs | HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g. |
| OG003 | 220 mg/1 g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g. |
| OG004 | 220 mg/5 g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g. |
| OG005 | 150 mg/1 g Mild Renal Impairment (RI) | Mild RI (creatinine clearance [CL] 60-90) with dabigatran (DE) 150 mg/Ida 1g |
| OG006 | 150 mg/5 g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g |
| OG007 | 150 mg /2*2.5 g Moderate RI (CL 30-60) | Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart. |
|
|
Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
| OG002 | 220 mg/2.5g HS 45-64 Yrs Re-exposure | Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3 |
| OG003 | 220 mg/5g HS 45-64 Yrs | Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g |
| OG004 | 220 mg/Plc. 5g HS 45-64 Yrs | Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g. |
| OG005 | 220 mg/1g HS 65-80 Yrs | Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g. |
| OG006 | 220 mg/Plc. 1g HS 65-80 Yrs | Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g. |
| OG007 | 220 mg/5g HS 65-80 Yrs | Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g. |
| OG008 | 220 mg/Plc. 5g HS 65-80 Yrs | Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g. |
| OG009 | 150 mg/1g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g |
| OG010 | 150 mg/Plc. 1g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g |
| OG011 | 150 mg/5g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g |
| OG012 | 150 mg/Plc. 5g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g |
| OG013 | 150 mg /2*2.5g Moderate RI (CL 30-60) | Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart. |
| OG014 | 150 mg /Plc. 2*2.5g Moderate RI (CL 30-60) | Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart. |
|
|
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3 |
| OG003 | 220 mg/5g HS 45-64 Yrs | HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g. |
| OG004 | 220 mg/Plc. 5g HS 45-64 Yrs | HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g. |
| OG005 | 220 mg/1g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g. |
| OG006 | 220 mg/Plc. 1g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g. |
| OG007 | 220 mg/5g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g. |
| OG008 | 220 mg/Plc. 5g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g. |
| OG009 | 150 mg/1g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g |
| OG010 | 150 mg/Plc. 1g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g |
| OG011 | 150 mg/5g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g |
| OG012 | 150 mg/Plc. 5g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g |
| OG013 | 150 mg /2*2.5g Moderate RI (CL 30-60) | Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart. |
| OG014 | 150 mg /Plc. 2*2.5g Moderate RI (CL 30-60) | Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart. |
|
|
| OG003 | 220 mg/1 g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g. |
| OG004 | 220 mg/5 g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g. |
| OG005 | 150 mg/1 g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g |
| OG006 | 150 mg/5 g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g |
| OG007 | 150 mg /2*2.5 g Moderate RI (CL 30-60) | Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart. |
|
|
| OG003 | 220 mg/1 g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g. |
| OG004 | 220 mg/5 g HS 65-80 Yrs | HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g. |
| OG005 | 150 mg/1 g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g |
| OG006 | 150 mg/5 g Mild RI (CL 60-90) | Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g |
| OG007 | 150 mg /2*2.5 g Moderate RI (CL 30-60) | Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart. |
|
|